Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057783 | PMC |
| http://dx.doi.org/10.1093/infdis/jiz389 | DOI Listing |
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